Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
1705–1728 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 01, 2010
ELECSYS TROPONIN I CALCHECK 5
K100594 · JJX
Roche Diagnostics
Chemistry · 30d
Cleared Apr 01, 2010
CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267
K093506 · CGA
Taidoc Technology Corporation
Chemistry · 140d
Cleared Mar 30, 2010
BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
K092849 · CEM
Epocal, Inc.
Chemistry · 195d
Cleared Mar 29, 2010
ELECSYS CK-MB CALCHECK 5
K093582 · JJX
Roche Diagnostics
Chemistry · 130d
Cleared Mar 26, 2010
CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265
K093941 · CGA
Taidoc Technology Corporation
Chemistry · 94d
Cleared Mar 22, 2010
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
K093732 · JIX
Siemens Healthcare Diagnostics
Chemistry · 108d
Cleared Mar 19, 2010
ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810
K100293 · JIT
Siemens Heatlhcare Diagnostics, Inc.
Chemistry · 45d
Cleared Mar 19, 2010
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL...
K093492 · JJY
Diamond Diagnostics, Inc.
Chemistry · 129d
Cleared Mar 19, 2010
ELECSYS TROPONIN T CALCHECK 5
K092848 · JJX
Roche Diagnostics Corp.
Chemistry · 184d
Cleared Mar 15, 2010
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091555 · NBW
Taidoc Technology Corporation
Chemistry · 292d
Cleared CT Mar 12, 2010
DIDGET WORLD REPORTS
K093930 · NBW
Bayer Healthcare, LLC
Chemistry · 80d
Cleared Mar 12, 2010
LIQUICHEK OPIATE CONTROL
K093577 · DIF
Bio-Rad Laboratories
Chemistry · 114d
Cleared Mar 10, 2010
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
K093384 · JJY
Diamond Diagnostics, Inc.
Chemistry · 131d
Cleared Mar 10, 2010
INTEGRATED LABORATORY AUTOMATION SOLUTION
K091975 · CGA
Integrated Laboratory Automation...
Chemistry · 252d
Cleared Mar 05, 2010
EXL ANEM CAL, MODEL RC640
K093645 · JIX
Siemens Healthcare Diagnostics
Chemistry · 100d
Cleared Mar 05, 2010
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE...
K092740 · CGN
Abbott Laboratories
Chemistry · 178d
Cleared Mar 05, 2010
NEONATAL BIOTINIDASE KIT, MODEL 3018
K090123 · NAK
Perkinelmer, Inc.
Chemistry · 408d
Cleared Mar 04, 2010
ELECSYS HCG STAT CALCHECK 5
K093700 · JJX
Roche Diagnostics Corp.
Chemistry · 93d
Cleared Mar 02, 2010
SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM
K093764 · NBW
Biotest Medical Corp.
Chemistry · 85d
Cleared Feb 25, 2010
ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM,...
K093592 · NBW
Taidoc Technology Corporation
Chemistry · 98d
Cleared Feb 24, 2010
BASESENS BLOOD GLUCOSE MONITORING SYSTEM
K093475 · NBW
Hygeia, Inc.
Chemistry · 110d
Cleared Feb 24, 2010
EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
K092894 · NBW
Eps Bio Technology Corp.
Chemistry · 156d
Cleared Feb 19, 2010
INTOUCH DIABETES
K093789 · NBW
Symcare Personalized Health...
Chemistry · 72d
Cleared Feb 19, 2010
FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING...
K093712 · NBW
Taidoc Technology Corporation
Chemistry · 79d